NCT05370612

AT GOAL: Adopting Technology for Glucose Optimization and Lifestyle in Pregnancy

Continuous Glucose Monitoring in Pregnant Patients With Type 2 Diabetes, a Mixed Methods Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).

Detailed description

This pilot single site randomized control trial will compare the blood glucose control and participant satisfaction scores of continuous glucose monitoring vs standard glucose checks in pregnant women with a prior diagnosis of Type 2 diabetes. The study population will consist of 40 women who are less than 20 weeks pregnant at time of enrollment who have a pre-pregnancy diagnosis of Type 2 diabetes. Participants will be randomized to one of two treatment arms. * Arm 1: Placement of Dexcom G6 continuous glucose monitor for glucose monitoring for duration of pregnancy * Arm 2: Continuation of standard glucose finger sticks with placement of a blinded Dexcom Pro G6 continuous glucose sensor for two ten day periods (at enrollment and again at 28-32 weeks gestation) Participant accrual will occur over 18 months at 1 site. Participants will complete 3 study visits, all of which will be in conjunction with previously scheduled prenatal or diabetes visits: at the time of consent (less than 20 weeks gestation), 28-32 weeks gestation, and 2-6 weeks postpartum.. Surveys will be administered at each time point. At the final visit, patients will be asked for participate in a 2-5 minute directed interview as well. * Primary Objective * To examine the feasibility of completing a study to assess for differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. * Secondary Objectives * To estimate the effect of continuous glucose monitoring devices placed prior to 20 weeks in pregnancy in patients with Type 2 diabetes on time in range, as measured between 28-32 weeks of pregnancy. * To assess patient satisfaction to continuous glucose monitoring during pregnancy * To estimate the effect of continuous glucose monitoring on the incidence of neonatal morbidity and mortality.

Conditions

• Type2Diabetes
• Pregnancy in Diabetic

Interventions

Type	Name	Description
DEVICE	Dexcom G6 CGM	Dexcom 6 CGM, an FDA approved device. Sensors will be placed on the abdomen per package instruction to collect continuous glucose data. Experimental Group will wear CGM for the duration of their pregnancy. Control Group will have CGM data collected for 10 days at enrollment and at 28-32 weeks into their pregnancy.
OTHER	Participant Finger Stick Glucose Monitoring	Standard of care for individual participant

Timeline

• Start date: 2022-08-08
• Primary completion: 2024-10-06
• Completion: 2024-10-06
• First posted: 2022-05-11
• Last updated: 2026-03-31
• Results posted: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study